The purpose of the study is to determine whether a steroid-eluting sinus implant is effective in improving chronic sinusitis symptoms in patients who experience recurrent blockage of the sinuses by polyps sometime after sinus surgery.

A significant proportion of patients who undergo sinus surgery for chronic sinusitis later experience recurrent symptoms due to persisting disease and the regrowth of sinus polyps. For many patients this persisting disease proves to be refractory to medical therapy. Treatment options typically include further aggressive medical therapy or repeat sinus surgery. This study is designed to evaluate another treatment option in the form of a steroid-eluting sinus implant that is placed into the sinus and delivers the medication for up to 3 months to reduce sinus inflammation, polyposis and the associated sinus symptoms.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

diagnosis of chronic sinusitis

prior sinus surgery with ethmoidectomy

recurrent sinus obstruction due to polyps

refractory to medical therapy

indicated for revision sinus surgery

Exclusion Criteria:

significant scarring of the sinus

insulin dependent diabetes

glaucoma or ocular hypertension

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732536